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Evaluation of Regional Ventilation Distribution Using Electrical Impedance Tomography During Weaning From Mechanical Ventilation

Evaluation of Regional Ventilation Distribution Using Electrical Impedance Tomography During Weaning From Mechanical Ventilation

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05726513
Acronym
WEAN-EIT
Enrollment
30
Registered
2023-02-14
Start date
2023-02-15
Completion date
2024-12-31
Last updated
2023-02-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Failure, Mechanical Ventilation Complication, Ventilator-Induced Lung Injury, Weaning Failure

Keywords

Electrical Impedance tomography, Weaning trial, Acute respiratory failure, Lung monitoring

Brief summary

The goal of this physiological cross-over clinical trial is to evaluate the effect of different clinically used weaning trials on regional mechanical ventilation in a population of patients undergoing weaning from mechanical ventilation for acute respiratory failure. The main question\[s\] it aims to answer are: * to evaluate which weaning trial is associated to a better regional ventilation distribution * to evaluate which weaning trial can be comparable to ventilation distribution after extubation Participants will undergo 3 clinically used weaning trials in a random order (cross-over trial). Researchers will compare the different steps to see if regional ventilation distribution is different among the different trial .

Interventions

DIAGNOSTIC_TESTWeaning trial - Low support, high Positive end-expiratory pressure

The researcher will evaluate the readiness to be weaned of the patient using a weaning trial with low pressure support ventilation and a positive end expiratory pressure of 5 cmH2O

DIAGNOSTIC_TESTWeaning trial - Low support, zero positive end-expiratory pressure

The researcher will evaluate the readiness to be weaned of the patient using a weaning trial with low pressure support ventilation and a positive end expiratory pressure of 0 cmH2O

DIAGNOSTIC_TESTWeaning trial - Zero support, zero positive end-expiratory pressure

The researcher will evaluate the readiness to be weaned of the patient using a weaning trial with 0 pressure support ventilation and a positive end expiratory pressure of 0 cmH2O

Sponsors

University of Milan
CollaboratorOTHER
Università degli Studi di Ferrara
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Age \> 18 and \< 70 years * Ready to be weaned from mechanical ventilation according to clinical criteria

Exclusion criteria

* Age \< 18 years or \> 70 years * Presence of chest drains * Presence of pacemaker/impantable cardiac device; * diagnosis of Pneumothorax, or pneumomediastinum * Diagnois of neuromuscular diseases * Use of neuromuscular blockers in the 48 hours before screening; * Body mass index \> 35 kg/m2 * Refusal to participate of the patient/next of kin

Design outcomes

Primary

MeasureTime frameDescription
Regional Ventilation distribution using Electrical Impedance Tomography2 hoursThe researchers will evaluate differences in ventilation distribution pattern among the different weaning trials using Electrical Impedance Tomography and focusing on: * Regional ventilation distribution * Regional inhomogeneity * Regional compliance distribution * Center of Ventilation * Silent Spaces

Secondary

MeasureTime frameDescription
Differences in Regional Ventilation distribution using Electrical Impedance Tomography between weaning trials and post-extubation phase48 hoursThe researchers will evaluate differences in ventilation distribution pattern among the different weaning trials and the post-extubation phase using Electrical Impedance Tomography and focusing on: * Regional ventilation distribution * Regional inhomogeneity * Regional compliance distribution * Center of Ventilation * Silent Spaces

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026